Kornimate/medical-research-clean huggingface dataset:
icg-coated endoscopic clip for tumor localization

Conditions: Colorectal Neoplasms

Summary: the fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery. the purpose of this study is to evaluate the efficacy of the localization of colonic lesions using icg coated endoscopic clip in laparoscopic colon surgery.


Eligibility criteria:
inclusion criteria: * cases which are deemed necessary to mark the location of the colon lesion before surgery exclusion criteria: * preoperative colonoscopy is not possible due to intestinal obstruction * if the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam * disagreement with the study
value of urodynamics prior to stress incontinence surgery 2

Conditions: Stress Urinary Incontinence

Summary: to test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence (sui) and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption.


Eligibility criteria:
inclusion criteria: * symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence * signs of stress urinary incontinence on physical examination or voiding-diary * patient is a candidate for surgical treatment (as based on history and physical examination) * patient has attended at least 3 months of physiotherapy * patient accepts randomisation * patient is capable to fill out bladder diary's, pad tests and questionnaires * patient understands the dutch written and spoken language * asa 1 or 2 exclusion criteria: * previous incontinence surgery * mixed urinary incontinence, urge component is predominant * prolapse \>= 1cm beyond the hymen on valsalva in supine position * postvoid urinary residual \> 150ml * present urinary tract infection * the need for additional pelvic surgery (prolapse and/or hysterectomy) * patient is or wants to become pregnant * prior pelvic radiotherapy

Keywords: stress urinary incontinence urodynamics randomized clinical trial surgery
open-label safety study to evaluate imiquimod cream, 5% for large areas of actinic keratosis

Conditions: Keratosis

Summary: actinic keratosis (ak) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. the purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of ak. the ak lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. the total surface area for the ak lesions must be greater than 25 cm2. the secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of ak.

this was a phase 4, open-label, single-arm, multicenter study in male and female subjects aged 18 years or older with clinically diagnosed ak lesions, conducted at 31 investigational sites in the united states. this study assessed the safety of imiquimod as a treatment for ak applied in doses ranging from one packet 12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles, depending upon treatment success and ak lesion recurrence. eligible subjects applied imiquimod 5% cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical, visible, discrete, nonhypertrophic ak lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline. multiple treatment areas could be exposed (i.e., head, torso and/or extremities), with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area, up to a maximum of 6 packets per dose. in each treatment cycle, dosing was to continue for 16 weeks (approximately 4 months), as instructed by the investigator, followed by a 2-month, treatment-free follow-up period.

Eligibility criteria:
inclusion criteria: * are at least 18 years of age. * have greater than 25 cm2 total treatment area(s) containing at least 4 actinic keratosis lesions. exclusion criteria: * have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema). * have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Keywords: actinic keratosis lesions large head torso extremities actinic keratosis
golimumab for adherence in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine if non-adherence to rheumatoid arthritis (ra) drugs in participants treated with biologic disease modifying anti-rheumatic drugs (dmards) is associated with a greater incidence of disease in clinical practice.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of rheumatoid arthritis * about to initiate therapy with golimumab * must sign a participation agreement/informed consent form (icf) allowing data collection and source data verification in accordance with local requirements exclusion criteria: * diagnosis of axial spondyloarthritis, ankylosing spondylitis or psoriatic arthritis * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point * currently enrolled in an investigational study * currently enrolled in an observational study sponsored or managed by a janssen company
cerebral changes following cts treated with guided plasticity

Conditions: Carpal Tunnel Syndrome

Summary: 70 patients with mild to moderate carpal tunnel syndrome (cts) including 24 patients with unilateral cts were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (emla®) or placebo during 8 weeks. patient-rated outcomes was assessed using the symptom severity scale from the boston carpal tunnel syndrome questionnaire (bctq) and the disability of arm, shoulder and hand questionnaire(quick-dash). clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (ncs). cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fmri) at 3t. assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.


Eligibility criteria:
inclusion criteria: * symptoms of cts for more than 3 months * classic or probable cts according to katz' hand diagram (2, 27) * clinical signs of unilateral cts with a positive tinel's and phalen's test * age between 18 and 70 years * nerve conduction studies (ncs) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side * no contraindications for mr examinations. exclusion criteria: * bilateral symptoms * having been operated for cts previously * prior wrist or carpal fracture * diabetes * thyroid disease * rheumatoid arthritis * neurological disease * drug abuse * complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.

Keywords: magnetic resonance imaging somatosensory cortex anesthesia hand
iodine i 131 in treating patients with thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: radioactive iodine kills thyroid cancer cells by giving off radiation. purpose: this clinical trial is studying the side effects, best dose, and how well iodine i 131 works in treating patients with thyroid cancer.

objectives: * determine the relationship between estimated absorbed dose of iodine i 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer. outline: patients receive oral dosimetric iodine i 131 (\^131i) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric \^131i. single-photon emission computed tomography (spect)/ct scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. subsequent spect/ct scans are performed over the candidate tumor sites. patients undergo \^131i therapy on day 11. saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. blood is collected at baseline and periodically during study to measure flt3 ligand levels. projected accrual: a total of 96 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of thyroid cancer * measurable disease by ct scan or nuclear medicine imaging * eligible, by standard of care criteria, for iodine i 131 therapy patient characteristics: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy) * no other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin * no nonthyroidal conditions known to affect iodine i 131 uptake (e.g., new york heart association class iii or iv congestive heart failure or renal failure) * no alcoholism or drug abuse within the past 2 years * no severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia) prior concurrent therapy: * no intravenous water-soluble radiographic contrast within the past 4 weeks * no iodinated contrast agent within the past 3 months * no concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids) * no other concurrent investigational drugs

Keywords: anaplastic thyroid cancer insular thyroid cancer thyroid gland medullary carcinoma recurrent thyroid cancer stage i follicular thyroid cancer stage i papillary thyroid cancer stage ii follicular thyroid cancer stage ii papillary thyroid cancer stage iii follicular thyroid cancer stage iii papillary thyroid cancer stage iva follicular thyroid cancer stage ivb follicular thyroid cancer stage ivc follicular thyroid cancer stage iva papillary thyroid cancer stage ivb papillary thyroid cancer stage ivc papillary thyroid cancer
restoration of physical function in patients following total knee replacement: comparison between resistive strength training exercises & ankle weights

Conditions: Knee Osteoarthritis

Summary: techniques used to restore the physical functions in tkr patients

to restore the physical functions in tkr patients by the use of ankle weights and resistance exercises. total 40 patients were included in this study and two groups had been formulated one as experimental and other as control. 2 sessions were given to each group for 6 weeks.

Eligibility criteria:
inclusion criteria: * age of patients above 40 years with total knee arthroplasty * 4-6 weeks following tkr exclusion criteria: * age less than 40 patients * concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease. * pain score more than 6/10
safety, tolerability, and immunogenicity of two formulations of v114 in healthy adults 50 years of age or older (v114-006)

Conditions: Pneumococcal Infections

Summary: the purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of v114 (v114-a and v114-b) and prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants ≥50 years of age in good health.


Eligibility criteria:
inclusion criteria: * good health; any underlying chronic illness must be documented to be in stable condition * highly unlikely to conceive through 6 weeks after administration of the study vaccine exclusion criteria: * prior administration of any pneumococcal vaccine * history of invasive pneumococcal disease (ipd) \[positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease * known hypersensitivity to any vaccine component * known or suspected impairment of immune function * received systemic corticosteroids for \>=14 consecutive days and has not completed treatment \<=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination * coagulation disorder contraindicating intramuscular vaccination * receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease * received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. autologous blood transfusions are not considered an exclusion criterion. * participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study * breast feeding * user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
partnered care: coordinated emergency department transitions for assisted living patients with alzheimer's disease and related dementias

Conditions: Alzheimer Disease or Associated Disorder

Summary: the goal of this observational study is to learn the feasibility, acceptability, appropriateness, and adherence to a case management intervention. partnered is a case management intervention that aims to reduce unnecessary hospital admissions by providing real-time, structured information and discharge support to emergency department providers via phone and fax. the intervention is led by chronic care managers employed by bluestone accountable care organization, a physician group primarily serving patients in assisted living centers.


Eligibility criteria:
inclusion criteria: * bluestone accountable care organization patient * registration in emergency department between november 1, 2023 and june 30, 2024, as recorded in electronic admission, discharge, and transfer notifications exclusion criteria: * none

Keywords: case management emergency department feasibility
vitamin d supplementation in critically ill children with respiratory disease

Conditions: Vitamin D Supplementation

Summary: to evaluate the role of vitamin d supplementation in critically ill children with respiratory disease regarding their outcome.

vitamin d is involved in the process of immunomodulation, especially in the context of autoimmunity . vitamin d has multiple pharmacological effects, such as alleviating the inflammatory response, promoting phagocytosis, and inducing lymphocyte proliferation . previous studies have demonstrated that patients with lower serum vitamin d levels had a longer length of hospital stay and might have an independent relationship with the duration of mechanical ventilation (mv) in critically ill children . approved vitamin d supplementation regimens: the recommended daily allowance (rda) or adequate intake (ai) suggested by the institute of medicine (iom) and supported by health canada are 400 iu for infants and 600 iu for older children. approved high-dose regimens: in addition to rda, the iom provides a higher age-specific dose called the tolerable upper intake level (ul), which ranges from 1,000 to 4,000 iu.

Eligibility criteria:
inclusion criteria: * all pediatric patients admitted in picu with respiratory disease with age from 1month to 16 years. exclusion criteria: * patients admitted in picu due to causes rather than respiratory disease.
spi-guided analgesia during cea under ra

Conditions: Carotid Artery Stenoses

Summary: the aim of this randomized prospective trial is to assess the utility of adequacy of anaesthesia technique (response entropy and surgical pleth index) for monitoring pain perception intraoperatively, maintainance of hemodynamic stability during anesthesia and its influence on postoperative outcomes, in patients undergoing carotid endarterectomy under cervical plexus block.

carotid artery stenosis constitutes a major risk factor for ischemic stroke so carotid endarterectomy is performed to protects patients with severe atherosclerotic carotid artery stenosis against stroke. surgical pleth index (spi) is reported to properly reflect nociception-antinociception balance in patients undergoing surgical procedures, where a value of 100 corresponds to a high stress level and a value of 0 to a low stress level; values near 50 or increase in value \> delta 10 correspond to the stress level which is known to reflect requirement for rescue analgesia. a randomized interventional trial to evaluate the effects of spi-guided rescue analgesia on hemodynamic stability during anesthesia in patients undergoing carotid endarterectomy under cervical plexus block.

Eligibility criteria:
inclusion criteria: clinical diagnosis of stenosis of carotid artery written consent to participate in the study written consent to undergo carotid endarterectomy under regional anaesthesia of cervical plexus using moore's technique general heath condition i-iii of american society of anaesthesiology exclusion criteria: * necessity of administration of vasoactive drugs influencing spi monitoring pregnancy * anatomical malformation that make monitoring using se sensor impossible * general atherosclerosis and heart rhythm disturbances impairing spi monitoring * chronic medication using opioid drugs leading to resistancy to opioids. * farmacotherapy with anticoagulants * allergy to local anaesthetics

Keywords: surgical pleth index (spi) cervical plexus block adequacy of anaesthesia (aoa state entropy stroke
early breast feeding and glucose levels in high risk newborns

Conditions: Neonatal Hypoglycemia

Summary: early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. however, little data is available regarding its contribution to glucose levels in the newborn infants. newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

mothers will be encouraged to breast feed early after delivery (at the delivery room). data of high risk babies for developing post partum hypoglycemia (infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 kg or less than 2.5 kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. glucose levels shall be routinely monitored and recorded at the neonatal department. a comparison of all data will be made between those newborns that breast feed after labor and those who were not.

Eligibility criteria:
inclusion criteria: * newborns to diabetic mothers * newborns to hypertensive mothers * newborns with birth weight greater than 4 kg or less than 2.5 kg * newborns with meconium stained amniotic fluid exclusion criteria: * newborns with major congenital malformation * preterm babies * newborns with post-birth distress

Keywords: early breast feeding hypoglycemia newborn
comparing triamcinolone acetonide mucoadhesive films with licorice mucoadhesive films

Conditions: Mucositis

Summary: abstract: background: complementary and alternative medicine (cam) had proven efficacy in pain relief, correction of nutritional status and improving the performance status. however, lack of standardization is the major obstacle for any scientific evaluation of any cam trial. mucositis is a major complication of irradiation in head and neck (h\&n) tumors, the addition of chemotherapy to irradiation may enhance this dose limiting problem. licorice is a strong demulcent that had been effectively used in treatment of peptic ulcer. the main purpose of this study was to compare the therapeutic safety and efficacy of t. and l. mucoadhesive films on oral mucositis in terms of pain control and/or ulcer treatment. methods and materials: the study was a double-blind, randomized prospective trial of two types of mucoadhesive films in the management of oral mucositis occurred during head and neck cancer ( hnc ) radiotherapy. oral mucositis was assessed using a quantitative scale (who scales) and symptoms were assessed using visual analogue scales (vas). 60 patients were enrolled in the study; there were 30 patients in the triamcinolone (t) and 30 in the licorice (l) group. in the t- group, patients received triamcinolone acetonide mucoadhesive films containing 1mg of the drug and patients in the l- group received licorice mucoadhesive films, an herbal agent. data were collected at baseline, then twice a week for 4 weeks.


Eligibility criteria:
inclusion criteria: * over 18 years of age * men and nonpregnant women * women of childbearing age who were non-pregnant by pregnancy test and and using medically prescribed contraceptive * no previous radiation therapy applied in the head and neck * medically fit for a course of radical radiotherapy * an ability to remain in the study for its entire duration exclusion criteria: * pregnant women * women of childbearing potential in whom medically prescribed birth control was not used * concurrent chemotherapy * history of heavy alcohol or drug abuse judged to be important by the investigator - concomitant therapy with an investigational drug, or cancer chemo therapeutics or immunosuppressive medications * sensitivity or intolerance to triamcinolone or licorice, lactose or similar formulations * inability to provide informed consent * actively bleeding gastric ulcer, severe esophageal reflux * major surgery, trauma or burns in the preceding 4 weeks * clinically significant hepatic, neurologic, endocrine, or other systemic disease-making implementation of the protocol or results difficult.

Keywords: irradiation mucositis triamcinolone acetonide licorice mucoadhesive film
phase 2 study of epi-743 for treatment of rett syndrome

Conditions: Rett Syndrome

Summary: rett syndrome is a severe neurodevelopmental disorder that primarily affects female children. rett syndrome is characterized by significant elevation in blood markers of oxidative stress. epi-743 is a novel therapeutic with demonstrated efficacy and safety in the treatment of disorders characterized by oxidative stress. the purpose of this study is to examine the safety and efficacy of epi-743 in a population of children with rett syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis of rett syndrome with disease stage 1-2 * abnormality of at least two disease biomarker levels * confirmed mecp2 mutation * patient or patient's guardian able to consent and comply with protocol requirements * abstention from use of coenzyme q10, vitamin e and idebenone two weeks prior to enrollment into the study exclusion criteria: * any condition, which in the opinion of the investigator could compromise the subject's safety or adherence to treatment with epi-743. * clinically significant allergy or hypersensitivity to epi-743 or to any of the excipients of with epi-743 (eg., sesame oil). * clinically significant allergy or hypersensitivity to vitamin e * lack of confirmation of mecp2 mutation * clinical history of bleeding or abnormal baseline pt/ptt * diagnosis of any other concurrent inborn error of metabolism * hepatic insufficiency with lfts greater than 3 times upper limit of normal * renal insufficiency requiring dialysis * end stage cardiac failure * fat malabsorption syndromes precluding drug absorption

Keywords: rett syndrome epi-743 edison